study to assess the safety and efficacy of etoricoxib versus ibuprofen in the treatment of dysmenorrhea (mk-0663-145 am1)

Conditions: Dysmenorrhea

Summary: this is a study to determine the overall analgesic effect of a single oral dose of etoricoxib compared to ibuprofen in participants with moderate-to-severe primary dysmenorrhea.

participants who meet all the study entry criteria will be randomly allocated to 2 possible sequences of the 2 treatment regimens over the course of 2 menstrual cycles. in treatment sequence 1, participants will receive etoricoxib 120 mg daily in menstrual cycle 1, and ibuprofen up to 2400 mg/daily in menstrual cycle 2. in treatment sequence 2, participants will receive ibuprofen up to 2400 mg/daily in menstrual cycle 1 and etoricoxib 120 mg daily in menstrual cycle 2.

Eligibility criteria:
inclusion criteria: * agree to remain abstinent or use double-barrier contraception throughout the study. participants who are status post tubal ligation are exempt from this requirement. * moderate or severe primary dysmenorrhea during a minimum of 4 of the previous 6 menstrual cycles. moderate: over-the-counter analgesics provide significant relief in most menstrual cycles; discomfort interferes with usual activity. severe: over-the-counter analgesics not consistently effective, or prescription analgesics required in at least some menstrual cycles; discomfort is incapacitating causing an inability to work or do usual activity. * willing to limit alcohol intake to 2 drinks or equivalent per day for the duration of the study and follow-up period as well as to avoid exercise during the first 24 hours postdose in each menstrual cycle. * able to read, understand, and complete diary. exclusion criteria: * use of an intrauterine device. pregnant, breast feeding, or \<6 weeks postpartum. * active gastric ulcer or history of inflammatory bowel disease. * uncontrolled hypertension. * uncontrolled diabetes mellitus or renal disease. * class ii-iv congestive heart failure. * coronary artery bypass graft surgery, angioplasty, myocardial infarction, cerebrovascular accident or transient ischemic attack within the past 6 months. * unstable angina. * mild, moderate, or severe hepatic insufficiency. * any personal or family history of an inherited or acquired bleeding disorder. * history of neoplastic disease; exceptions: 1)adequately treated basal cell carcinoma or carcinoma in situ of the cervix; 2) other malignancies which have been successfully treated \> or equal to 5 years prior to screening. participants with a history of leukemia, lymphoma, malignant melanoma, and myeloproliferative disease are ineligible for the study regardless of the time since treatment. * allergic to etoricoxib, ibuprofen, acetaminophen, indomethacin, or other nonsteroidal anti-inflammatory drugs (nsaids), or cyclooxygenase (cox)-2 inhibitors, or to components in saridon (propyphenazone/paracetamol/caffeine). * recent history of chronic analgesic or tranquilizer use or dependence. * morbidly obese and demonstrates significant health problems stemming from the obesity. * current user of recreational or illicit drugs or had a recent history of drug or alcohol abuse or dependence. * participated in another clinical study within the last 4 weeks. * not able to swallow oral medications: surgical or anatomical conditions that will preclude from swallowing and absorbing oral medications on an ongoing basis.